Ginkgo biloba extract in peripheral arterial diseases. Meta-analysis of controlled clinical studies]

In the first part the statistical methods of meta-analysis are discussed. Meta-analysis is considered as a statistical tool for quantitatively summarizing the results of clinical trials with comparable aims (treatments) and designs. Meta-analysis can be based on the significance probabilities or effect values. The last procedure is preferable as it gives an estimate (and confidence interval) for the global effect of the treatment of interest, if homogeneity of the effects between the trials can be assumed. Such a homogeneity can be often achieved by a suitable standardization of the effect variables within the trials. In the second part the methods of meta-analysis are applied to controlled clinical trials with Ginkgo biloba extract EGb 761 in patients with peripheral arterial disease. Included were 5 placebo-controlled clinical trials with similar design and inclusion criteria. In all studies treatment effect was quantified by the increase of walking distance (measured in standardized treadmill exercise). The effect value of EGb 761 treatment was expressed by the standardized mean difference in walking distance increase between EGb 761 and placebo, standardized by the standard deviation. It could be shown that this effect value is homogeneous in all trials. The global effect size was estimated as 0.75. This means that the mean increase in walking distance achieved by EGb 761 is 0.75 times of the standard deviation higher than that achieved by placebo. This value is highly significant different from zero. So the meta-analysis revealed a highly significant therapeutic effect of EGb 761 for the treatment of peripheral arterial disease.     

Erb:YAG and Hol:YAG laser ablation of meniscus and intervertebral discs.

Erb:YAG and Hol:YAG laser ablation rates of fibrocartilage and nucleus pulposus were measured in vitro simulating clinical conditions. After ablation macroscopic and microscopic appearance of the ablation site was investigated. Hol:YAG and Erb:YAG laser mean ablation rates increased almost linearly with rising energies, showing higher total ablation rates for the Hol:YAG laser due to its higher achievable energy density. At comparable energy densities the Erb:YAG laser appears to be more effective with respect to the corresponding ablation rates. Consequently, the ablational threshold proved to be lower for the Erb:YAG laser. Whereas during Hol:YAG laser ablation, some smoke formation and considerable tissue shrinking occurred, these effects could not be observed during Erb:YAG laser ablation. Consequently macroscopic and microscopic inspection showed some thermal damage after Hol:YAG and only minimal alterations after Erb:YAG laser ablation. Adjacent thermal damage was determined and proved to be lower for the Erb:YAG laser. In our opinion the characteristics of each laser system provide certain advantages for special clinical indications.     

Cytostatic and immunomobilizing activities of polymer-bound drugs: experimental and first clinical data.

An N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer carrier containing doxorubicin and human immunoglobulin as an actively/passively targeting moiety was used in four patients with generalized breast cancer resistant to standard cytotoxic chemotherapy. The dose and time schedule were deduced from a Phase I clinical trial in which doxorubicin bound to HPMA copolymer carrier (PK1) was tested. It was confirmed that the Dox-HPMA-HuIg conjugate is stable and doxorubicin remains in the peripheral blood with a small amount also in the urine, mostly in its polymer-bound form. More than 116 biochemical, immunological and hematological parameters were determined for blood samples taken from patients 24 h, 48 h, 72 h and 1 to 11 weeks after treatment. Depending on the patient, some parameters decreased permanently or temporarily to the normal level (CRP, C3, CA 72-4, beta(2)-microglobulin, ferritin, CEA, CA 125, CD4, CD8, CE19, CD16(+)56(+), leu, ery) and some moved markedly towards physiological values (AST, ALT, ALP, GMT, CA 15-3, NSE, AFP). While the number of peripheral blood reticulocytes was significantly decreased after treatment with the classical free drug, their number was not affected or was even elevated after treatment with Dox-HPMA-HuIg. Increased absolute numbers of CD16(+)56(+) and CD4(+) cells in the peripheral blood and activation of NK and LAK cells in all patients support data obtained in experimental animals, pointing to a dual, i.e. cytostatic and immunomobilizing character of Dox-HPMA conjugates containing a targeting immunoglobulin moiety.     

Sozialmedizinische Maßnahmen

During the seventies and eighties of the 20th century, France reported a considerable decline in the overall rate of preterm deliveries. The figure for all births before 37 weeks gestation dropped from 8.2% in 1972 to 4.9% in 1988, and births before 34 weeks accounted for 2.4% of all births in 1972 and 0.9% in 1988. This development was paralleled by the creation of a national program for the active support of women, children and families. This program was aimed at improving medical care, together with financial and social support, in particular for education and improved working conditions for mothers inside as well as outside of the home. Surprisingly, in the nineties a rise in the rate of preterm deliveries was noticed and in a national survey in France the number for all deliveries before 37 weeks was 6.8% in 1998 and 2.0% for the early preterm deliveries. A similar development was also seen in other countries. This could not be explained by changes in socio-medical support programs. Instead, it was related to a rise in the mean age of pregnant women as well as to the development of assisted reproduction. The example of France demonstrates that a political initiative for the support of women, children and families is not only effective in reducing the number of preterm deliveries but also has a positive effect on the national fertility rate. In Europe, France together with Ireland, with 1.89 children per women, rank at the top of the list of national fertility rates. The mean for Europe is 1.41 and countries like Spain and Italy, with fertility rates of 1.22 and 1.25, are at the end of the list.     

Integrated home monitoring predicts lead failure in a pacemaker dependent 4-year-old girl.

A 4-year-old girl with post-surgical complete atrioventricular block received an epicardial dual chamber pacemaker system. During further growth intermittent exit block occurred, first misinterpreted as neurological seizures. The epicardial lead was replaced using a transvenous approach, and a pacemaker with an integrated home monitoring facility was implanted. After her discharge, a rise in the pacing threshold automatically initiated an event message. On the basis of this information, the patient was called in and imminent dislodgement of the ventricular lead was diagnosed by x-ray. The lead was repositioned and was found stable over 1-year follow-up.     

Osteoporose: eine Volkskrankheit?

Zusammenfassung Im folgenden Beitrag werden die Ursachen der Osteoporose und ihre Behandlungsmöglichkeiten dargestellt. Diskutiert werden verschiedene Strategien zur Prävention anhand beeinflussbarer und nicht beeinflussbarer Risikofaktoren sowie die Möglichkeiten, das Frakturrisiko zu reduzieren. Von besonderem Interesse sind Therapien mit und ohne Östrogenzusatz, wie z. B. die Calciumsubstitution, die Vitamin-D₃-Substitution, die singuläre Östrogentherapie sowie die Therapie mit Bisphosphonaten und selektiven Östrogenrezeptormodulatoren. Die Östrogentherapie ist die Therapie der Wahl bei Osteporose. Abstract The following article presents the causes of osteoporosis and possible treatment modalities. Various strategies for prevention are discussed based on modifiable and nonmodifiable risk factors as well as measures to reduce fracture risk. Of particular interest are therapy regimens with and without estrogen supplements, e.g., calcium substitution, vitamin D₃ substitution, single estrogen therapy, and treatment with bisphosphonates and selective estrogen receptor modulators. Estrogen therapy is the treatment of choice for osteoporosis.